NCT05763849 Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
| NCT ID | NCT05763849 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Anorexia Nervosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-03-14 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-03-14 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project includes a parallel group randomized controlled trial comparing two psychological treatments: 1) Exposure-based Family Therapy (IE) vs. 2) Family Based Therapy (FBT) for low weight eating disorders with 12 month follow-up. Primary outcomes are expected body weight and clinical impairment. Three mechanisms of change (Autonomous Eating, Non-Judgmental Body Awareness, and Extinction Learning) will be examined in a process mediation models of change.
Eligibility Criteria
Inclusion Criteria: * Aged 12-18 * Speak English * Permission from pediatrician or equivalent to receive outpatient care * Clinically significant restriction of food intake by EDA-5 or evidence of persistent food avoidance from patient or guardians * Evidence of the inability to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories Exclusion Criteria: * Comorbid psychotic or bipolar disorder * Active suicidal ideation * Current substance dependence * Psychiatric medication initiated or dosage changes \<2 weeks from baseline * Major medical illness (e.g., diabetes mellitus, Crohn's disease, etc.)
Contact & Investigator
Thomas Hildebrandt, Psy.D.
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT05763849 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05763849 currently recruiting?
Yes, NCT05763849 is actively recruiting participants. Contact the research team at tom.hildebrandt@mssm.edu for enrollment information.
Where is the NCT05763849 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05763849 clinical trial?
NCT05763849 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Thomas Hildebrandt, Psy.D. at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 120 participants.